BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DTC MARGRON HIP REPLACEMENT SYSTEM

    MDR report key: 1021856 · Received March 28, 2008

    Report

    Report Number
    9613642-2008-00016
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 6, 2006
    Report Date
    March 28, 2008
    Manufacturer
    PORTLAND ORTHOPAEDICS LTD.
    Product Code
    HTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A 6MM REAMER BROKE DURING SURGERY, AND THE SURGEON WAS UNABLE TO RETRIEVE FROM BONE (FEMUR). IT WAS NOT BELIEVED THAT THIS WOULD BE LIKELY TO CAUSE A DEATH OR SERIOUS INJURY AND THE SURGEON ELECTED TO LEAVE THE BROKEN PART IN SITU. IT ALSO IS UNDERSTOOD BY THE COMPANY THAT AN EVENT OF THIS NATURE TO BE NOT UNCOMMON. THE DESIGN OF THE REAMERS WERE SUBSEQUENTLY REVISED TO PREVENT OR FURTHER LIMIT THE LIKELIHOOD OF A REAMER BREAKAGE DURING USE. NO FURTHER CASES OF BREAKAGE HAVE BEEN REPORTED TO DATE. ALL INSTRUMENTS ARE EXAMINED BY PORTLAND FOR SIGNS OF WEAR AND TEAR AFTER EACH SURGICAL PROCEDURE PRIOR TO DISPATCHING, AND CHECKED AGAIN BY THE SURGICAL TEAM PRIOR TO BEING USED IN A PROCEDURE. DAMAGED OR BROKEN INSTRUMENTS ARE REPLACED WITH NEW INSTRUMENTS. THE EVENT IS BEING REPORTED FOLLOWING A REASSESSMENT BY PORTLAND ORTHOPAEDICS. THE REASSESSMENT WAS CONDUCTED AFTER A TREND REGARDING EARLY REVISION RATES WITH THE MARGRON DEVICE WAS OBSERVED BY ANOTHER COUNTRY ORTHOPAEDIC ASSOCIATION IN ITS 2007 NATIONAL JOINT REGISTRY REPORT. THIS OBSERVED TREND AND PORTLAND'S INITIAL ANALYSES WERE PREVIOUSLY REPORTED TO FDA IN MDR NO. 9613642-2008-00001. AS A PRECAUTIONARY MEASURE, PORTLAND HAS TAKEN THE MARGRON DTC SYSTEM OFF THE MARKET IN THE U.S. PENDING FURTHER EVALUATION OF THE DEVICE AND EVENTS, EXCEPT FOR CASES IN WHICH MARGRON-SPECIFIC TOOLS OR COMPONENTS ARE NECESSARY TO PERFORM REVISION OF A MARGRON IMPLANT.

    Description of Event or Problem · 1

    SURGICAL INSTRUMENT FAILURE DURING PRIMARY IMPLANTATION OF MARGRON HIP REPLACEMENT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DTC MARGRON HIP REPLACEMENT SYSTEM DISTAL REAMER DIA. 6MM (INSTRUMENT) HTO PORTLAND ORTHOPAEDICS LTD. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 DTC FEMORAL NECK AZ| LOT# 953| DTC FEMORAL STEM Z+0| CERAMIC FEMORAL HEAD 32M| LOT# 653